Trial Outcomes & Findings for Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors (PROGRESS) (NCT NCT02224482)
NCT ID: NCT02224482
Last Updated: 2021-10-12
Results Overview
Adaptive coping was measured with the Cancer Coping Questionnaire. The total score from the Cancer Coping Questionnaire is a mean scale. There were a total of 14 items, each with a Likert-type 4-point scale, with 1 being the minimum value and 4 being the maximum value. A higher score indicated greater coping ability (i.e., better outcome).
COMPLETED
NA
431 participants
Change in coping from baseline to six months
2021-10-12
Participant Flow
Participant milestones
| Measure |
Control
Print materials
|
Intervention Group
PROGRESS
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.
|
|---|---|---|
|
Overall Study
STARTED
|
214
|
217
|
|
Overall Study
COMPLETED
|
63
|
57
|
|
Overall Study
NOT COMPLETED
|
151
|
160
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Different counts due to missing data
Baseline characteristics by cohort
| Measure |
Control
n=214 Participants
Print materials
|
Intervention Group
n=217 Participants
PROGRESS
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.
|
Total
n=431 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 7.5 • n=214 Participants
|
63.8 years
STANDARD_DEVIATION 6.7 • n=217 Participants
|
63.5 years
STANDARD_DEVIATION 7.1 • n=431 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=214 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=431 Participants
|
|
Sex: Female, Male
Male
|
214 Participants
n=214 Participants
|
217 Participants
n=217 Participants
|
431 Participants
n=431 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
143 Participants
n=214 Participants • Different counts due to missing data
|
160 Participants
n=217 Participants • Different counts due to missing data
|
303 Participants
n=431 Participants • Different counts due to missing data
|
|
Race/Ethnicity, Customized
Black
|
51 Participants
n=214 Participants • Different counts due to missing data
|
40 Participants
n=217 Participants • Different counts due to missing data
|
91 Participants
n=431 Participants • Different counts due to missing data
|
|
Race/Ethnicity, Customized
Other
|
18 Participants
n=214 Participants • Different counts due to missing data
|
17 Participants
n=217 Participants • Different counts due to missing data
|
35 Participants
n=431 Participants • Different counts due to missing data
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=214 Participants • Different counts due to missing data
|
0 Participants
n=217 Participants • Different counts due to missing data
|
2 Participants
n=431 Participants • Different counts due to missing data
|
|
Region of Enrollment
United States
|
214 participants
n=214 Participants
|
217 participants
n=217 Participants
|
431 participants
n=431 Participants
|
|
PSA at diagnosis (ng/ml)
|
8.6 ng/ml
STANDARD_DEVIATION 10.7 • n=214 Participants
|
14.0 ng/ml
STANDARD_DEVIATION 49.0 • n=217 Participants
|
11.4 ng/ml
STANDARD_DEVIATION 35.6 • n=431 Participants
|
|
Prostate cancer treatment completed
Surgery Only
|
131 Participants
n=212 Participants • Counts different due to missing data
|
130 Participants
n=213 Participants • Counts different due to missing data
|
261 Participants
n=425 Participants • Counts different due to missing data
|
|
Prostate cancer treatment completed
Radiation Only
|
50 Participants
n=212 Participants • Counts different due to missing data
|
59 Participants
n=213 Participants • Counts different due to missing data
|
109 Participants
n=425 Participants • Counts different due to missing data
|
|
Prostate cancer treatment completed
Other (multiple treatments)
|
31 Participants
n=212 Participants • Counts different due to missing data
|
24 Participants
n=213 Participants • Counts different due to missing data
|
55 Participants
n=425 Participants • Counts different due to missing data
|
PRIMARY outcome
Timeframe: Change in coping from baseline to six monthsPopulation: Data provided for participants with six month data
Adaptive coping was measured with the Cancer Coping Questionnaire. The total score from the Cancer Coping Questionnaire is a mean scale. There were a total of 14 items, each with a Likert-type 4-point scale, with 1 being the minimum value and 4 being the maximum value. A higher score indicated greater coping ability (i.e., better outcome).
Outcome measures
| Measure |
Control
n=106 Participants
Print materials
|
Intervention Group
n=103 Participants
PROGRESS
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.
|
|---|---|---|
|
Adaptive Coping
|
-0.089 score on a scale
Standard Deviation 0.559
|
-0.013 score on a scale
Standard Deviation 0.602
|
SECONDARY outcome
Timeframe: Change from baseline to six monthsThis will be measured using the Urinary Incontinence Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary incontinence (i.e., better outcome).
Outcome measures
| Measure |
Control
n=101 Participants
Print materials
|
Intervention Group
n=96 Participants
PROGRESS
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.
|
|---|---|---|
|
Physical Functioning - Urinary Incontinence
|
9.240 score on a scale
Standard Deviation 19.671
|
10.750 score on a scale
Standard Deviation 21.933
|
SECONDARY outcome
Timeframe: Change from baseline to six monthsThis will be measured using the Urinary Irritation Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary irritation (i.e., better outcome).
Outcome measures
| Measure |
Control
n=100 Participants
Print materials
|
Intervention Group
n=94 Participants
PROGRESS
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.
|
|---|---|---|
|
Physical Functioning - Urinary Irritation
|
10.063 score on a scale
Standard Deviation 17.200
|
7.979 score on a scale
Standard Deviation 16.660
|
SECONDARY outcome
Timeframe: Change from baseline to six monthsThis will be measured using the Bowel Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less bowel problems (i.e., better outcome).
Outcome measures
| Measure |
Control
n=102 Participants
Print materials
|
Intervention Group
n=97 Participants
PROGRESS
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.
|
|---|---|---|
|
Physical Functioning - Bowel
|
1.479 score on a scale
Standard Deviation 13.330
|
3.119 score on a scale
Standard Deviation 14.847
|
SECONDARY outcome
Timeframe: Change from baseline to six monthsThis will be measured using the Sexual Functioning Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less sexual problems (i.e., better outcome).
Outcome measures
| Measure |
Control
n=98 Participants
Print materials
|
Intervention Group
n=96 Participants
PROGRESS
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.
|
|---|---|---|
|
Physical Functioning - Sexual Functioning
|
4.793 score on a scale
Standard Deviation 19.829
|
3.046 score on a scale
Standard Deviation 21.402
|
SECONDARY outcome
Timeframe: Change from baseline to six monthsSatisfaction with communication in medical interactions will be assessed with the medical interactions scale from the Cancer Rehabilitation Evaluation System (CARES): difficulty communicating with the medical team, and problems obtaining information from the medical team. The minimum value is 0 and the maximum value is 4. A higher score means patients had worse medical interactions (i.e., worse outcome).
Outcome measures
| Measure |
Control
n=103 Participants
Print materials
|
Intervention Group
n=96 Participants
PROGRESS
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.
|
|---|---|---|
|
Interpersonal Concerns - Medical Interactions
|
-0.311 score on a scale
Standard Deviation 2.783
|
-0.531 score on a scale
Standard Deviation 2.554
|
SECONDARY outcome
Timeframe: Change from baseline to six monthsSatisfaction with marital communication will be assessed from the marital problems scale from the Cancer Rehabilitation Evaluation System (CARES). The minimum value is 0 and the maximum value is 4. A higher score means more marital problems (i.e., worse outcome).
Outcome measures
| Measure |
Control
n=95 Participants
Print materials
|
Intervention Group
n=88 Participants
PROGRESS
PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.
|
|---|---|---|
|
Interpersonal Concerns - Marital Interactions
|
-0.042 score on a scale
Standard Deviation 3.956
|
0.182 score on a scale
Standard Deviation 3.358
|
Adverse Events
Control
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place